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Bethesda,
Maryland20892

Purpose:

This study will examine prostate tumor tissue cultures to try to identify genetic
abnormalities that contribute to the cause or progression of the disease.
Patients with prostate cancer enrolled in the National Cancer Institute protocol 97-C-0147
(Collection of Serum and Tissue Samples from Patients with Biopsy-Proved or Suspected
Malignant Disease) may be eligible for this study.
Specimens for tissue culture for this study will be obtained from tumors surgically removed
from patients participating in NCI protocol 97-C-0146.
The findings of this study may lead to better methods of predicting the course of disease in
individual patients.

Study summary:

Prostate cancer is the most common solid tumor in American males and the most common
malignancy among men in Western industrialized countries. Widespread testing for early
detection of prostate cancer utilizing digital rectal examination and prostate specific
antigen (PSA) has led to a significant clinical conundrum. Differentiating organ confined
indolent disease from aggressive cancer has been imperfect. Nonetheless, increased
detection has led to increased radical prostatectomies. A prevailing goal of the
contemporary, ardent research seeks to discover a molecular biomarker for prognostication.
Given the limitations of the current knowledge of the molecular pathology of prostate
cancer, there are several viewpoints regarding the process of tumorigenesis. However, a
generally accepted hypothetical model describes normal prostatic epithelium progressing to a
pre-malignant or low-grade prostatic intraepithelial neoplasia (PIN). Then, after further
genetic alterations, a succession of histologically apparent adenocarcinoma--first confined,
then metastatic, and finally refractory to hormone treatment ensues. Current molecular
research has shown already complex genetics alterations at the high-grade prostatic
intraepithelial neoplasia stage. Thus, invasive disease represents amplification or further
aberration of precursor events. The seminal event or events have not been recognized and
the undiscovered tumor suppressor gene or proto-oncogene may be a principal tumor marker.
The purpose of this study is to identify specific, shared, consistent, chromosomal
rearrangements found in metaphase preparations for short-term cultures of pathologically
identified and scored primary prostate tumors. These, tumor specimens will be obtained from
patients enrolled in protocol (97-C-0147) by the NCI. Fresh tumor, taken from bi-valved
specimens with one half undergoing tissue pathology, will be immediately placed in growth
media and transferred as a coded specimen as a sample from patients selected and enrolled in
protocol (97-C-0147). Informed consent will be obtained by participating investigators in
the NCI protocol. The outcome measurement will be the characterization, or failure of
characterization, of specific, shared consistent, chromosomal rearrangements. Current
molecular cytogenetics technologies, primarily utilizing chromosomal microdissection, will
be employed toward this goal. Ultimately, this research may help to focus further molecular
studies towards the ultimate goal of finding a unique, cancer specific alteration.

Criteria:

INCLUSION CRITERIA:
Only patients who have met pathologic criteria for prostate intraepithelial neoplasia or
higher (determined by pathologists included in the NCI protocol) will be included for
entry into this protocol.
EXCLUSION CRITERIA:
No prisoners, decisionally impaired, healthy volunteers, or lab personnel will be included
in this study.

NCT ID:

NCT00022919

Primary Contact:

N/A

Backup Contact:

N/A

Location Contact:

Bethesda, Maryland 20892United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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